Multicenter Double-blind Placebo-controlled Comparative Randomized Study of the Tolerability, Safety, Immunogenicity and Prophylactic Efficacy of the EpiVacCorona Peptide Antigen-based Vaccine for the Prevention of COVID-19, With the Participation of 3000 Volunteers Aged 18 Years and Above (Phase III-IV)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
- Enrollment
- 3000
- Locations
- 8
- Primary Endpoint
- The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, within 6 months post vaccination versus a placebo
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective of the clinical study is to evaluate the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine in volunteers aged 18 and above.
The study tasks are to:
- evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;
- evaluate the tolerability of the EpiVacCorona vaccine when administered twice intramuscularly;
- identify any adverse events to the administration of the EpiVacCorona vaccine;
- investigate the humoral immune response following two doses of the EpiVacCorona vaccine;
- investigate the cell-mediated immune response following two doses of the EpiVacCorona vaccine;
- evaluate the prophylactic efficacy of the EpiVacCorona vaccine when administered twice intramuscularly.
Detailed Description
The study will screen a maximum of 4,929 volunteers of both sexes aged 18 and above, of which 3,000 volunteers who meet the inclusion criteria and do not have the exclusion criteria will be randomized: * 2,250 volunteers who will be vaccinated with the EpiVacCorona vaccine, twice intramuscularly at a dose of 0.5 ml; * 750 volunteers who will be vaccinated with a placebo, twice intramuscularly at a dose of 0.5 ml. If volunteers drop out of the study, they will not be replaced. All volunteers will be followed up by an investigator physician for 6 months following the first vaccination in order to identify possible late adverse events. In case the volunteer has any late reactions, he/she will be invited to the clinic to correct his/her condition.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Availability of a signed and dated informed consent of the volunteer to participate in a clinical trial, prior to any of the study procedures.
- •Volunteers (men and women) above the age of 18 years with stable indicators of basic vital functions.
- •Ability to attend all scheduled visits and all planned procedures and examinations.
- •Consent of volunteers to use effective contraceptive methods throughout the study, including the observation period for possible post-vaccination reactions.
Exclusion Criteria
- •History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or another coronavirus infection (HCoV-229E, HCOV-OC43, HCoV-NL63, HCoV-HKU1).
- •History of exposure to confirmed or suspected cases of SARS-CoV-2 infection within 1 month prior to randomization.
- •Positive for IgM or IgG to SARS-CoV-2 as detected during screening.
- •Positive PCR test for SARS-CoV-2 as detected during screening.
- •Clinically and laboratory (according to PCR data) confirmed disease caused by SARS-CoV-2 coronavirus, at the moment or in the past.
- •Serious post-vaccination reaction (body temperature above 40 °C , hyperemia or edema greater than 8 cm in diameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination; convulsions, with or without of a febrile state) to a previous vaccination in the past.
- •Aggravated allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, history of serum disease, history of hypersensitivity or allergic reactions to the administration of any vaccines, any known allergic reactions to vaccine components, etc.).
- •Hypersensitivity to any component of the product, allergy to vaccine components.
- •History of vaccination with any vaccine within one month prior to randomization.
- •Previous vaccination with rabies vaccines less than 2 months prior to randomization, or planned vaccination with rabies vaccines within 1 month after immunization with the vaccine under study.
Outcomes
Primary Outcomes
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, within 6 months post vaccination versus a placebo
Time Frame: within 6 months after the first vaccination
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 6 months post vaccination versus a placebo
The prophylactic efficacy of the vaccine
Time Frame: 9 months after the first vaccination
The prophylactic efficacy of the vaccine under study is ≥50% compared to a placebo, with the lower limit of the confidence interval of the point estimate for the primary efficacy variable \> 30%
Secondary Outcomes
- The frequency of severe cases of COVID-19 following a single / double vaccination(through the whole study, an average of 9 months)
- Duration of disease(through the whole study, an average of 9 months)
- The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies(21-28 days after the second vaccination)
- The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers(21-28 days after the second vaccination)
- The incidence of asymptomatic COVID-19 following a single / double vaccination(through the whole study, an average of 9 months)